In most surgical procedures, one or more of the steps in the procedure is the fastening of tissue. Not only does skin tissue require fastening, but fastening of various organ tissues, fascia tissue, muscle tissue, and other types of tissue may be required. Until the recent past, fastening of tissue has been accomplished almost entirely with sutures. In an effort to reduce the time required in the tissue fastening steps, the surgical profession has begun to replace sutures with metallic staples.
The metallic fasteners are slowly being accepted by the medical and surgical community. However, metallic fasteners do suffer from certain disadvantages; for example, they are foreign bodies which the body must cope with during recuperation after the surgical procedure. Furthermore, metallic staples and fasteners may disrupt and interfere with various subsequent diagnostic imaging techniques, such as x-ray, computerized axial tomography, or magnetic resonance imaging.
Polymeric tissue fastening devices, especially such devices which are absorbable by the body, show promise of eliminating these disadvantages of the metallic fastener. Devices of this nature are described in U.S. Pat. Nos. 4,060,089, 4,402,445, 4,317,451, and 4,428,376. Though the desirability of producing such fastening devices from polymeric materials, especially from absorbable polymeric materials, has been well known, as suggested in the above-mentioned patents, these devices have been slow to commercialize because it has been difficult to develop a fastener that is sterilizable, non-toxic, and has the mechanical properties required to be able to penetrate tissue without having complicated guiding and support devices to aid in that penetration, and to also maintain the tissue closed or fastened for a sufficient period of time to allow for the requisite healing of tissue, to then be absorbed within a reasonable period of time, and to do all of this with an article of minimum bulk.
It is an object of this invention to produce a fastening device that will not disrupt subsequent diagnostic procedures. It is also an object of this invention to produce a non-toxic, sterilizable, polymeric tissue fastening device that readily penetrates tissue. It is yet a further object of the invention to produce such a minimum bulk device that, once it has been placed to fasten tissue together, will maintain its strength for a sufficient period of time to allow for the healing of that tissue, and to then be absorbed by the body. These and other objects of the invention will be more fully appreciated from the following description.